Study Summary
This trial will compare two different treatments for recurrent Clostridium difficile infection, to see which is more effective.
Eligible Conditions
- Vancomycin
- Clostridium
- C. Difficile
- Fidaxomicin
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Day 90 since randomization
Day 59
Determine symptom resolution during treatment without any of the following: diarrhea recurrence; other non-fatal clinical events including severe abdominal pain, toxic megacolon, and colectomy; and death.
Day 59 since randomization
Sustained clinical response (CDI-COM)
Sustained clinical response (D-COM)
Day 90 since randomization
C.diff Health Related Quality of Life (HRQOL)
CDI Composite outcome measure
Diarrhea Composite outcome measure
Diarrhea recurrence
Symptom resolution
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
0 Treatment Group
549 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 90 since randomization
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,485 Previous Clinical Trials
2,741,670 Total Patients Enrolled
Stuart B. Johnson, MD BAStudy ChairEdward Hines Jr. VA Hospital, Hines, IL
Dale N Gerding, MDStudy ChairEdward Hines Jr. VA Hospital, Hines, IL
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:At least one of the previous CDI episodes must have been confirmed by a stool assay for C
Who else is applying?
What state do they live in?
| Arizona | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
How responsive is this trial?
Typically responds via
| Phone Call | 100.0% |
References
- Johnson, Stuart, Dale N. Gerding, Xue Li, Domenic J. Reda, Curtis J. Donskey, Kalpana Gupta, Matthew Bidwell Goetz, et al.. 2022. “Defining Optimal Treatment for Recurrent Clostridioides Difficile Infection (option Study): A Randomized, Double-blind Comparison of Three Antibiotic Regimens for Patients with a First or Second Recurrence”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106756.
- Johnson, Stuart, Dale N. Gerding, Xue Li, Domenic J. Reda, Curtis J. Donskey, Kalpana Gupta, Matthew Bidwell Goetz, et al.. 2022. “Defining Optimal Treatment for Recurrent Clostridioides Difficile Infection (option Study): A Randomized, Double-blind Comparison of Three Antibiotic Regimens for Patients with a First or Second Recurrence”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106756.
- Johnson, Stuart, Dale N. Gerding, Xue Li, Domenic J. Reda, Curtis J. Donskey, Kalpana Gupta, Matthew Bidwell Goetz, et al.. 2022. “Defining Optimal Treatment for Recurrent Clostridioides Difficile Infection (option Study): A Randomized, Double-blind Comparison of Three Antibiotic Regimens for Patients with a First or Second Recurrence”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106756.
- 2015. "Optimal Treatment for Recurrent Clostridium Difficile". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02667418.
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Conditions
Cancer Related
Treatments